Regulatory Operations Specialist

1 month ago


Livingston, West Lothian, United Kingdom ICON plc Full time
About ICON plc

ICON plc is a world-leading healthcare intelligence and clinical research organization. Our mission is to shape the future of clinical development by fostering an inclusive environment that drives innovation and excellence.

We're seeking a skilled Director, Regulatory Operations to join our dynamic team. As a key member, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

Responsibilities
  • Lead and oversee regulatory operations activities to ensure compliance with applicable regulations and guidelines.
  • Develop strategies for regulatory submissions and approvals, including INDs, NDAs, BLAs, and marketing authorization applications.
  • Collaborate with cross-functional teams to provide regulatory guidance and support throughout the drug development process.
  • Manage regulatory submissions and timelines, ensuring accuracy and completeness of documentation.
  • Stay abreast of evolving regulatory requirements and trends to inform decision-making and strategy development.
Requirements
  • Bachelor's degree in a scientific or related field.
  • 8+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
  • Strong understanding of global regulatory requirements and guidelines.
  • Proven track record of successful regulatory submissions and approvals.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams and with regulatory agencies.
What We Offer
  • A competitive salary range: $120,000 - $180,000 per year, depending on location and experience.
  • An annual leave entitlement of 20-25 days, depending on location and seniority.
  • A range of health insurance offerings to suit your needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • A Global Employee Assistance Programme offering 24-hour access to a global network of professionals who can support you and your family's well-being.
  • Lifelong learning opportunities to enhance your skills and career prospects.
Diversity, Inclusion & Belonging

All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. At ICON, diversity, inclusion, and belonging are fundamental to our culture and values, and we strive to create a workplace where everyone feels valued and empowered to succeed.



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